Australia-based regenerative medicine firm Orthocell has started patient enrolment in a clinical trial of its tendon regeneration therapy Ortho-Autologous Tenocyte Injection (ATI) to treat rotator cuff tendinopathy and shoulder joint tear.
The two injuries are reported to decrease the quality of life due to considerable disability, and are said to be a significant burden on healthcare resources.
Ortho-ATI technology is an advanced cellular therapy used on damaged or degenerate tendons resistant to existing conventional therapies.
The clinical trial will compare the effectiveness of Ortho-ATI with the corticosteroid injection in patients who have failed previous traditional treatment options such as injection treatment and physiotherapy.
Orthocell managing director Paul Anderson said: “Demonstrating the efficacy of Ortho-ATI for the treatment of rotator cuff tendinopathy is an important element of our product development and partnering strategy.
“We expect results to show Ortho-ATI is a durable and effective treatment for degenerative shoulder injuries.”
According to results from previous studies, Ortho-ATI is found to be a cost-effective, long-term and durable non-surgical treatment for difficult tendon injuries.
In Australia, New Zealand, and Hong Kong, Ortho-ATI is available with regulatory oversight for patients who have ongoing symptoms after the failure of treatment options such as corticosteroid injections and exercise programmes.
The Ortho-ATI injection involves a small healthy tendon piece being taken from the patient and sent to the firm’s laboratory, where tenocytes are isolated and grown to a clinically significant number.
The cells are then implanted into the affected tissue around four to five weeks after the initial biopsy.